Draft Guidance for Industry and Food and Drug Administration Staff

Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act

Document issued on: August 16, 2011


Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act) is one means by which the Food and Drug Administration (FDA) can obtain additional safety and/or effectiveness data for a device after it has been cleared through the premarket notification (510(k)) process or approved through the premarket approval application (PMA), humanitarian device exemption (HDE), or product development plan (PDP) process, when it is necessary to protect the public health. Postmarket surveillance is not a substitute for obtaining the necessary premarket information to support 510(k) clearance or PMA, HDE, or PDP approval.

Section 307 of the FDA Amendments Act of 2007 (FDAAA) (Pub. L. 110-85) amended section 522 of the act by adding class II and class III devices expected to have significant use in pediatric populations as a category of devices potentially subject to a postmarket surveillance order, authorizing the agency to order postmarket surveillance for durations longer than 36 months and as a condition of clearance or approval for devices within this category, and adding a dispute resolution provision.

This guidance document is intended to assist those subject to section 522 postmarket surveillance imposed by FDA by providing:

  • an overview of section 522 of the act,
  • procedural information on how to fulfill 522 obligations, and
  • recommendations on the format, content, and review of postmarket surveillance study submissions.

Substantive additions to the 2006 version of this guidance document include: (1) guidance regarding the pediatric criterion added by section 307 of FDAAA; (2) recommendations for the content of postmarket surveillance study submissions, consistent with previous FDA requests; (3) descriptions of study status categories that more precisely indicate study progress and the adequacy of the data; and (4) updated procedures based on the transfer of the program area to Division of Epidemiology (DEPI), Office of Surveillance and Biometrics (OSB).

Legal Background

  1. Statutory Criteria
  2. Considerations Regarding Pediatric Population Provisions
  3. Postmarket Surveillance Study Duration

Pre-522 Postmarket Surveillance Process

  1. Identification of Issue
  2. Team Review of Issue
  3. Issuance of 522 Order

Postmarket Surveillance Study Plans

  1. Elements to Include in a Postmarket Surveillance Study Plan
  2. FDA and Sponsor Agreement on Study Plan
  3. Changes to an Approved Postmarket Surveillance Study Plan
  4. Types of Postmarket Surveillance

Interim Postmarket Surveillance Study Reports

  1. Submission of Interim Postmarket Surveillance Study Report
  2. Sponsor’s Reporting Status
  3. Evaluation of Interim Postmarket Surveillance Study Status Report

Final Postmarket Surveillance Study Reports

  1. Submission of Final Postmarket Surveillance Study Report
  2. Sponsor’s Reporting Status
  3. Evaluation of Final Postmarket Surveillance Study Report

Content and Format of Interim and Final Postmarket Surveillance Study Reports

  1. General Information
  2. Submission Information
  3. Study Information

Study Status Determination

Where to Submit Postmarket Surveillance Study Submissions

Failure to Complete a Postmarket Surveillance Study

Public Disclosure of a Postmarket Surveillance Study

Download FDA Guidance

Download “522 Postmarket Surveillance Studies” ucm268141.pdf – Downloaded 385 times – 244 KB

Last Updated: 2016-05-04

FDCA 522 Postmarket Surveillance